RecruitingPHASE4INTERVENTIONAL

Therapeutic Relevance of Abnormal Airway Morphology in Asthma

This study, called AirPATH, is for people with asthma whose symptoms aren't fully controlled by regular inhalers. We want to find out if the shape or condition of a person's airways can prevent inhaled medicines from working properly. Think of it like a bumpy road stopping a car; narrow or blocked airways might stop inhaled medicine from getting to the right place. We're using advanced scans, like MRI and CT, to look closely at the airways. We'll then compare how well inhaled medicines work compared to oral (taken by mouth) medicines in these patients. The aim is to understand better why some asthma treatments aren't effective for everyone and hopefully find better ways to help them.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

McMaster University

Enrolment target

242

Start

02 Jun 2025

Estimated completion

01 Jun 2028

Asthma

What is this study about?

Many people with asthma find relief using their regular inhalers, but for some, their symptoms, breathing, and risk of asthma attacks don't improve much. This can be very frustrating, and we want to understand why this happens so we can find better solutions.

One idea is that sometimes, even if you use your inhaler correctly, the medicine might not reach all the areas of your lungs that need it. This could be because the airways are narrowed, blocked by mucus, or have other changes due to asthma. Imagine trying to drive a car down a road that's closed or full of potholes – it would be hard to get where you need to go. Similarly, these airway issues might stop inhaled medicine from getting deep into your lungs.

In this study, we're using special scanning techniques, like MRI and CT scans, to get a detailed look at people's airways. We'll use these pictures to see if the structure of their airways affects how well both inhaled and oral medicines work. We believe that if airways are abnormal, inhaled medicine might not be as effective, but oral medicines, which travel through your bloodstream, might still work well. By understanding this, we hope to improve treatments for those who don't get enough relief from their current inhalers.

Key takeaways

Looks at why inhalers don't always work for some people with asthma.
Uses special MRI and CT scans to examine your airways.
Compares how inhaled and oral medicines affect asthma.
You'll use your usual inhalers, with extra inhaled or oral steroids.
Aims to find better ways to treat those with difficult asthma.

Who may be eligible?

This study is looking for adults aged 18 or over who have been diagnosed with asthma by a lung specialist. You should be someone whose asthma isn't fully controlled, even with your regular inhalers, and show signs of inflammation in your airways when tested.

There are certain things that would mean you can't join the study. For example, if you've smoked recently, are pregnant or breastfeeding, have taken oral steroids in the last month, or certain biologic medicines in the last six months. Also, if you have other serious lung conditions or any metal in your body that prevents you from having an MRI scan, you wouldn't be able to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Has a lung doctor diagnosed you with asthma?
Do you feel your asthma isn't well controlled, even with your inhaler?
Have you smoked in the last year? (If yes, you likely can't join.)
Are you able to have an MRI scan? (No certain metal in your body, no severe claustrophobia, etc.)
Are you able to follow study instructions and attend appointments?

Answer every question to see your result.

What does participation involve?

If you join the study, it will be in two main parts over 12 weeks. You'll continue using your usual asthma inhalers. During the first part, you'll receive an increased dose of your inhaled steroid medicine for 12 weeks. After a short break, you'll enter the second part where you'll switch to a course of oral steroid tablets for a short period.

Throughout the study, you'll have several visits to the clinic for tests including breathing tests, blood tests, and sputum samples (coughing up mucus). You'll also undergo detailed scans of your lungs, like MRI and CT scans, to get clear pictures of your airways. We will also check your inhaler technique to make sure you're using it effectively. You'll need to answer questionnaires about your asthma symptoms and how you're feeling. The total duration of your participation, including all follow-ups and breaks, will be explained fully by the study team.

Potential risks and benefits

Participating in this study might offer you the benefit of close monitoring of your asthma and a potential improvement in your symptoms if either the increased inhaled steroid or the oral steroid treatment is effective for you. However, there are also risks, such as potential side effects from the medications, like increased inhaled steroids or oral steroids, and discomfort from procedures like blood tests or scans. Attending appointments will also require your time. You are completely free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

St. Joseph's Healthcare Hamilton
Verified postcode
Hamilton, Canada· Recruiting
Western University
Verified postcode
London, Canada· Not yet recruiting

Common questions

What kind of scans will I have?

You will have special scans called MRI (Magnetic Resonance Imaging) and CT (Computed Tomography) scans to get detailed pictures of your airways.

Will I stop my current asthma medicine?

No, you will continue with your usual asthma inhalers throughout the study. We will be adding to your inhaled steroid dose or switching to oral steroids for specific periods.

What does 'uncontrolled asthma' mean in this study?

It means your asthma symptoms aren't fully managed, even with your regular inhalers, and you're still experiencing symptoms or attacks.

What are 'oral corticosteroids'?

These are steroid medicines that you take by mouth, usually as tablets, which work throughout your whole body.

How long will the study last for me?

The main part of the study involves 12 weeks of increased inhaled steroid, followed by a period where you take oral steroids. You'll have several appointments during and after these periods.

How to find out more

Sarah Svenningsen, PhD

svennins@mcmaster.ca (905) 522-1155 Ext. 32195 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.